Senate calls on Health Canada to improve monitoring of off-label drug use

Antidepressants among drugs most often prescribed for non-approved uses

Health Canada urged to set up an efficient way to monitor the adverse reactions of drugs" prescribed off-label.

Photograph by: Postmedia News / Files
, Postmedia News

OTTAWA — Canada needs to rapidly adopt nationwide electronic medical systems to better understand how Canadians are reacting to “widespread” use of off-label prescription drugs, a new report from the Senate science committee says.

“It’s inexcusable that we are so late getting to a full electronic interaction of the medical system with patients and with Health Canada,” committee chair Kelvin Ogilvie told Postmedia News.

Health Canada does not monitor off-label prescription drug use and data on how often Canadian physicians prescribe drugs to treat conditions other than the ones they’re approved for are not available. However, a 2012 Quebec study found that one in nine drugs were prescribed for off-label use.

The study showed anticonvulsants, antipsychotics and antidepressants were among the drugs most often prescribed for non-approved uses.

Antipsychotics, which are approved for treatment of conditions such as schizophrenia and bipolar disorder in adults, were of particular concern to some appearing before the committee. These drugs are often prescribed off-label to children with behavioural issues such as attention deficit disorder, autism spectrum disorder and disruptive behaviour disorder. Health Canada has warned physicians of serious adverse reactions associated with children prescribed antipsychotics.

Off-label drug use is not inherently bad – in fact, many people can benefit from innovative off-use prescriptions of drugs, particularly if they have cancer or a rare disease – but Ogilvie said there is no understanding of what off-label prescribing is safe because Health Canada “has not set up an efficient and effective way to monitor the adverse reactions of drugs” prescribed off-label.

Currently, patients who experience adverse reactions to drugs can file a report with Health Canada. But few people know they can do this and “navigating from Health Canada’s homepage to the online reporting form is lengthy and not intuitive,” the Senate report notes.

Ogilvie said he suspects fewer than three per cent of adverse drug reactions are reported. And those reports don’t distinguish between reactions from intended and off-label drug use. He said this could be improved by getting electronic health records and electronic prescribing up and running across the country. This would alert physicians right away if they’re prescribing drugs for off-label use and would allow this information to be recorded, tracked and analyzed in real time.

Physicians can sometimes be unaware that they’re prescribing drugs off-label. This is the case when drugs are prescribed for an approved use but for an unapproved group. For example, many drugs are not approved for use in children, seniors or pregnant women.

More than a decade ago, Canada spent millions of dollars to create a non-profit independent body to develop electronic health systems, but progress has been slow – something Ogilvie attributes to “our fascination with protecting patients’ data.”

In the meantime, and even after electronic systems are in place, Ogilvie said Health Canada can proactively collect data on reactions to off-label drug use by partnering with the country’s pharmacists who could call patients and check in with them after filling their prescriptions. Such a system is being used by some training hospitals in the United States in partnership with the Food and Drug Administration.

“That would be the ideal way of doing it,” Ogilvie said. “We think that Health Canada could work with the pharmacists to have a really good monitoring and follow up on adverse reactions to patients in Canada.”

The Senate report is the third in a series of four studies on prescription pharmaceuticals in Canada. The fourth and final report on unintended consequences of prescription drugs is expected before the House rises for summer break.

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